Waters E2695 Separations Module (Refurbished)

Overview

The Waters E2695 Separations Module is a modular, high-performance liquid chromatography (HPLC) system engineered for robustness, method transfer fidelity, and regulatory compliance in QC, R&D, and contract laboratory environments. As a core component of the Alliance family, the E2695 integrates a quaternary solvent manager, sample manager with integrated column oven, and optional detector modules—including the 2489 UV/Vis or 2998 Photodiode Array (PDA)—to support gradient elution, method development, and routine analysis across pharmaceutical, environmental, food safety, and academic applications. Its design adheres to fundamental HPLC principles: precise solvent delivery via dual-piston positive displacement pumps, low-dead-volume flow paths to minimize band broadening, and temperature-stabilized autosampling to ensure injection reproducibility. The system operates under isocratic or gradient conditions, supporting reversed-phase, normal-phase, ion-exchange, and size-exclusion chromatography methodologies.

Key Features

• Quaternary solvent delivery system with active proportioning and real-time pressure monitoring, enabling seamless gradient programming and high baseline stability.
• Sample Manager with 120-position 2 mL vial capacity, needle-in-loop injection architecture, and wash station for carryover reduction—validated to <0.005% residual.
• Integrated column oven (ambient +5 °C to 85 °C) with dual-zone temperature control for independent regulation of analytical and guard columns.
• High-pressure capability up to 34.5 MPa (5000 psi), compatible with sub-2 µm particle-packed columns for UHPLC-ready separations when paired with appropriate detectors and tubing.
• Modular detector compatibility: supports 2489 UV/Vis (190–700 nm, ±1 nm wavelength accuracy), 2998 PDA (190–800 nm, 1.2 nm resolution), and third-party mass spectrometry interfaces via analog/digital I/O.
• Embedded Windows CE-based controller with local method storage, event logging, and USB export—designed for standalone operation or integration into enterprise LIMS environments.

Sample Compatibility & Compliance

The E2695 accommodates standard 4.6 mm ID analytical columns (50–250 mm length), microbore (1–2 mm ID), and narrow-bore (2.1 mm ID) formats. It accepts aqueous, organic, and mixed mobile phases—including TFA, HFBA, and ammonium acetate buffers—within pH 1.0–12.0 limits. All fluidic components are chemically resistant stainless steel or PEEK-lined, minimizing metal ion leaching and ensuring compatibility with chelating analytes. The system meets essential requirements for GLP and GMP workflows: audit trail functionality (when operated with Empower 3 CDS), electronic signature support per 21 CFR Part 11, and traceable calibration records. It aligns with ASTM D7097 (HPLC system suitability), ISO 17025 clause 5.9 (method validation), and USP Chromatography guidelines for system suitability testing.

Software & Data Management

The E2695 is fully supported by Waters Empower 3 Chromatography Data System (CDS), providing full instrument control, peak integration, reporting, and compliance tools. Empower 3 enables multi-user role-based access, automated system suitability assessment (e.g., tailing factor, resolution, %RSD of retention time), and raw data archiving with SHA-256 hashing. For laboratories requiring lightweight operation, the embedded controller allows method execution without external PC dependency—ideal for dedicated QC assays. Data export conforms to AIA (.cdf) and ASCII formats for third-party statistical analysis (e.g., JMP, Minitab). All firmware revisions are validated against Waters’ release notes and documented per internal change control SOPs.

Applications

• Pharmaceutical quality control: assay, related substances, dissolution testing, and stability-indicating methods per ICH Q2(R2).
• Biopharmaceutical characterization: monoclonal antibody purity profiling, peptide mapping, and glycan analysis using HILIC or SEC modes.
• Environmental analysis: PAHs, pesticides, and endocrine disruptors in water and soil extracts per EPA Methods 625.1 and 8330B.
• Food and beverage testing: preservatives (sorbates, benzoates), sweeteners (aspartame, sucralose), and mycotoxins (aflatoxin B1) per AOAC and ISO standards.
• Academic research: natural product isolation, polymer molecular weight distribution (SEC-MALS coupling), and kinetic studies via stopped-flow HPLC.

FAQ

Is this a factory-refurbished unit or dealer-refurbished?
All E2695 systems undergo certified refurbishment at an authorized Waters service center or ISO 13485-accredited facility, including full mechanical inspection, pump seal replacement, valve actuator calibration, and performance verification against factory specifications.
Does the system include a detector?
The base E2695 Separations Module does not include a detector; detector selection (e.g., 2489 UV/Vis, 2998 PDA) is configurable based on application requirements and budget constraints.
What documentation accompanies the instrument?
Each unit ships with a Certificate of Refurbishment, full maintenance log, as-delivered system suitability report, and original OEM user manuals—all traceable to serial number.
Can the E2695 be upgraded to support UHPLC pressures?
While the E2695’s maximum pressure rating is 34.5 MPa, it is not designed for sustained >60 MPa operation; for true UHPLC workflows, Waters recommends the ACQUITY UPLC H-Class platform.
Is remote diagnostics supported?
Yes—when connected to a local network and configured with Empower 3 Enterprise, the system supports secure remote troubleshooting via Waters’ SupportLink protocol, subject to customer firewall policies and IT approval.